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A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Double-blind, Randomized, Placebo Controlled, Combined Single and Multiple Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers

Clinical Trial Summary

This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants. This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5).

Clinical Trial Description

Part A (SAD): In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects. Part B (MAD): In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06309667
Study type Interventional
Source ProGen. Co., Ltd.
Contact Kyunghwa Son, Ph.D
Phone 02-6098-2818
Email bd@progen.co.kr
Status Recruiting
Phase Phase 1
Start date October 17, 2023
Completion date June 26, 2024
View Details
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